One Dead And Five In Hospital After French Drug Trial

An investigation has been launched after one person has reportedly died and another five were hospitalised after taking part in an experimental drug trial in France.

The hospital treating the remaining five patients said they remained in a stable condition.

It has been reported that four had "neurological problems" and the fifth had no symptoms.

All six patients were volunteers in a clinical trial being run by research company Biotrial for the reported drug manufacturers, Bial.

A spokesperson for the research company said the trial was being conducted in “full compliance with international regulations” and its own procedures, which includes health monitoring.

The French health ministry announced what it called a “serious accident” on Friday, saying the trial had been suspended and all volunteers recalled.

A statement released did not reveal the name of the drug being tested but French media reported claims it was a new cannabis-based painkiller.

French health minister, Marisol Touraine, said that the pill did not contain cannabis or its derivatives but acted on the body's endocannabinoid system.

The drug, which is taken orally, was undergoing a Phase 1 clinical trial at a licenced private European laboratory that specialises in clinical trials.

The trial aimed to evaluate the “safety, tolerance and pharmaceutical properties of the molecule” in healthy volunteers, a spokesperson said.

Ninety volunteers took the drug, 10 of the other 84 have been tested, but did not display any of the "anomalies" of those admitted, the Rennes University Hospital said in its statement.

Last week the chief neuroscientist at the hospital, Gilles Edan, said there was no known antidote to the drug.

In France, adults volunteering for Biotrial tests can earn between €100 and €4,500 (£76 to £3,400).

France’s medicines agency (ANSM) has launched an investigation into the laboratory.

The last major drug trial disaster in Europe occurred in 2006, when six healthy volunteers given an experimental drug at Northwick Park, London, ended up in intensive care with some suffering permanent and serious injuries.

Associate and product liability expert Tim Annett said it was an important that a thorough investigation into the trial was undertaken.

Expert Opinion

Whilst clinical trials are extremely important it is imperative that a thorough investigation takes place. Transparency is vital to ensure lessons can be learned, and to promote the safety of all those who participate in clinical trials.

There are always risks involved for those taking part in clinical trials, although in the majority of cases nothing serious is likely to happen. If something does go wrong the consequences can be devastating, as sadly appears to be the case here.

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